Blood vessels are commonly used as a conduit to access internal patient anatomy for assessing medical needs and performing surgical procedures. Access through blood vessels allows surgical procedures to be performed while greatly reducing trauma and recovery time for the patient. Such procedures are generally regarded as minimally invasive procedures in contrast to open surgery procedures, the latter of which cut a patient open for access and create much larger wounds to be closed following a surgical procedure.
In 1953, Sven Seldinger developed a minimally invasive percutaneous access technique that is still commonly used today. This technique, known as Seldinger access, typically consists of several basic steps. A blood vessel, such as the femoral artery, is punctured through the skin surface using a hollow syringe needle. A guidewire is threaded through the needle into the artery, and the needle is removed by sliding it out over the guidewire. A cannula known as a dilator is inserted through a larger diameter tube known as a sheath, and both are advanced over the guidewire into the blood vessel, thus also assisting with later closure of the wound by having minimized disruption of the wounded tissue. The dilator and guidewire are removed from the sheath, leaving the sheath spanning from the outside of the patient to the inside of the blood vessel. The sheath provides an access port to the inside of the blood vessel through which large-diameter catheters and other surgical instrumentation may be advanced into, and traversed around, the patient's body. The sheath also serves to seal the wound from bleeding prior to completion of a further medical procedure through the wound. An anticoagulant such as heparin is typically administered to the patient so that the instrumentation placed into the blood vessel does not precipitate dangerous blood clots within the vasculature. Upon completion of the medical procedure, all instrumentation and the sheath are removed from the patient. The access wound site is typically subjected to manual compression until a clot has established to sufficiently stop bleeding from the vessel wound.
The use of manual compression for wound closure following a minimally invasive percutaneous surgical procedure is the “gold standard” by which all alternative methods of wound closure are evaluated for safety, reliability, and efficacy. However, wound closure by manual compression can be a slow process, particularly in the presence of anticoagulants. This led to a plethora of wound closure inventions that sought to expedite wound closure. Some, by example Khosravi et al. in US Application 2005/0149117 A1, followed Seldinger's efforts to seal or assist sealing of percutaneous wounds early in the process of performing a percutaneous medical access procedure. Khosravi did this by early deployment of a wound closure approach selected from a broad choice of agents, materials, or devices to seal or assist in sealing a percutaneous wound site. Most similar to the present invention, Nowakowski in U.S. patent application Ser. No. 13/162,655, also advocated early deployment of an agent for wound closure and did so in a manner like the present invention, but failed to fully specify a different and substantial further beneficial utility of the approach employed, as will now become clearer in the prophylactic subject matter of the present invention. Despite the above prior art and numerous other percutaneous wound closing inventions, acceptable success rates remains elusive in the clinic due largely to external reasons, e.g., inherent anatomical variability in patients, with the resultant persistent bleeding complications regarded as far outweighing the cardiovascular complications of the primary reason for a surgical procedure. This is summarized in an article authored by Jackson Thatcher, MD, FACC, Director of Inpatient Cardiology for the Park Nicollet Heart Center at Methodist Hospital St. Louis Park, for Cath Lab Digest, (March 2008,) entitled “Groin Bleeds and other Hemorrhagic Complications of Cardiac Catheterization: A list of relevant issues” Volume 16 (Issue 3), retrieved from http://www.cathlabdigest.com/articles/Groin-Bleeds-and-Other-Hemorrhagic-Complications-Cardiac-Catheterization-A-list-relevant-is. The article lists percutaneous accessed arterial bleeds as the number one “ . . . major cause of morbidity and mortality associated with cardiac catheterization procedures and percutaneous coronary interventions” with failed percutaneous wound closure technologies alone comprising only a very small portion of the root causes cited. In contrast, the present invention compensates for the vast majority of root causes cited in the article, not by offering yet another percutaneous wound closure technology, but by providing a bather to protect a patient when a wound closure technology fails or is otherwise rendered ineffective in the presence of contributing factors.